Development And Evaluation Of TCM Scale Of Blood Stasis Syndrome

Objectives:The study was conducted to explore and compile a patient reported syndrome scale----blood-stasis syndrome(PRS-bss), to evaluate its reliability, validity and responsiveness. In order to provide a clear quantitative tool for the blood stasis patients by establishing a self rating scale. Methods:According to the international methods, relevant studies, literature reviews, textbook and standard collection, patient depth interview, and expert discussion, the entry pool was formed. Classifying the entries and setting the questions through the theoretical framework. After language debugging, the primary PRS-bss was formed by group consensus. Selecting the entries based on depth interview and clinical investigation. The index system was used to test the reliability, validity, and responsiveness by running a second clinical investigation. The final PRS-bss was established after revision. Results:Depth interviews were conducted with 42 patients, the data of which was collected and summarized to form a entry pool. Those entries were selected by expert discussion and clinical investigation to delete unsatisfactory ones. The scale is composed of 4 dimensions(activity, sleep, mood, and aggravation), and 10 entries. The retest reliabilities of summary and 4 dimensions are 0.954, 0.945, 0.976, 0.924, 0.959. The Cronbach’s coefficients were 0.829, 0.813, 0.614, 0.675, respectively. The correlation coefficient of each entry and the total score were higher than 0.4. Factor analysis showed 5 factors. Contribution rate reached 80%. The composition of the factor conformed to the theoretical conception. The correlation coefficient of the pain score was 0.741(P=0.000). The responsiveness was satisfying. Patient group and healthy group can be distinguished clearly. Conclusions: The PRS-bss is proved to have good reliability, validity, and responsiveness. Its clinical value needs further multi-center and large sample clinical trial. There are some defects in this scale to be revised and improved in the follow-up study.